How to Read a CLL Drug’s Package Insert (PI)

A drug’s package insert or PI is the most accessible and generally the most important free source of information about any medication. This is an underutilized resource by many chronic lymphocytic leukemia (CLL) patients, a disease where so many of the treatments are taken orally at home for long periods.

If the pharmacy supplies the medication in its original packaging, the PI should be included in the box. If not, CLL Society links to the PI for each commonly prescribed CLL treatment in the CLL Medicine Cabinet. In addition, the PI can almost always be easily found online by searching for the drug by name, branded or generic, followed by packet insert. So, in the case on the slides attached, one could simply search for “venetoclax package insert”, then click on the company’s website, then on prescribing information, and there you’ll find a downloadable PI.

But the PI is written for the healthcare professional (HCP) who will be prescribing it, not for the patient receiving it. It is definitely not in patient-friendly language. Its structure and contents are tightly controlled by the FDA, and it gets pretty deep into the weeds about everything a doctor needs to know about safely using the drug for any and all possible patients. Some special examples include the very old or the very young, those with failing kidneys or those who might be or become pregnant.

That is why I am so grateful to Paul Budworth, PhD whose career was focused on regulatory affairs in the pharmaceutical sector. Dr. Budworth’s work was instrumental in the FDA approval of important medications. He understands from both a drug company’s perspective and a chronic lymphocytic leukemia patient’s perspective what goes into a PI.

Dr. Budworth has prepared a PowerPoint presentation with helpful “speaker notes” that explain the slides, telling us what sections we might want to skip and where we might want to focus.

At CLL Society our mantra is “Smart Patients Get Smart Care”. Paul Budworth is helping us with that goal.